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Depo-Provera Label Change Highlights Risks and Ongoing Brain Tumor Lawsuits

The FDA has approved an update to Depo-Provera’s U.S. warning label as lawsuits alleging a link between the birth control shot and brain tumors continue to grow. Here’s what the label change means for ongoing litigation.

A man typing on a laptop with Food and Drug Administration approved certification digital documents.

Around 1 in 4 sexually active women in the U.S. have used Depo-Provera, the birth control shot, at some point in their lives. While its use has decreased somewhat in recent years as intrauterine devices (IUDs) rose in popularity, Depo-Provera is still a common choice among women to prevent pregnancy.

But the dangers of just one year of use of the shot have led to significant legal troubles for its manufacturer, Pfizer. And now, long after Canada and Europe changed Depo-Provera’s label to include the risk of brain meningiomas, the Food and Drug Administration (FDA) has approved Pfizer’s request to update product labels in the U.S.

The label change comes far too late for many women, as evidenced by the sheer number of Depo-Provera lawsuits against Pfizer that allege the birth control shot causes brain tumors. On top of the hundreds of individual cases, numerous cases were consolidated into multidistrict litigation in February 2025. As of December, the Depo-Provera brain tumor MDL has grown to include nearly 1,500 plaintiffs.

The product label update is generally thought to be a win among plaintiffs seeking compensation and accountability from Pfizer. At the very least, it validates their argument: there are known risks of brain meningiomas from use of the birth control shot – risks the manufacturer knew or should have known about long before now. Plaintiffs further allege that Pfizer’s failure to warn doctors and patients of those risks caused them to suffer unnecessarily, and that if they had known about the dangers, they may have chosen an alternate form of birth control.

Lawsuits Continue to be Filed Against Pfizer for Depo-Provera Brain Tumor Risks

Since mid-summer, the Depo-Provera MDL has more than tripled in size. There are a few factors that are likely to have caused the rapid growth of this litigation – growth that is expected to continue through 2026, possibly longer. A notable factor that’s led to more filings is greater awareness of medical research that has connected progestogens to brain tumors.

More women across the U.S. have learned about the recent research study that initially spurred the influx of Depo-Provera lawsuits at the beginning of 2025. The large-scale study published in the British Medical Journal found that women who used the birth control shot for at least one year had a 5.6-fold increased risk of developing brain meningiomas. While these tumors are often non-cancerous, the location can cause serious symptoms and complications, and surgical removal can be complex.

The research supported decades of other studies that associated brain meningiomas with high doses of progestogens, including medroxyprogesterone acetate, a key ingredient in Depo-Provera. In turn, women are realizing their suffering may have been caused by a product that didn’t have proper warnings, and are learning their legal options by discussing their cases with dangerous product lawyers.

Media coverage of the Depo-Provera brain tumor MDL, as well as individual lawsuits on top of that, has also impacted general awareness of the litigation against Pfizer. Product liability lawsuits of this magnitude tend to garner significant news coverage, helping to spread awareness of the associated risks of products.

What the Depo-Provera Label Change Means for Brain Tumor Lawsuits

Plaintiffs and other women considering taking legal action against Pfizer are now wondering what the label change on the birth control shot means for Depo-Provera lawsuits. While these cases are still in early stages, and more continue to be filed each week, lawyers for plaintiffs have doubled down on their argument that Pfizer knew of the risks for decades but failed to adequately warn consumers.

Attorneys have long argued that there are studies linking high doses of progestogens to brain tumors that date back to the 1980s, and that Pfizer ignored critical research. They allege such research should have led the manufacturer to investigate and act accordingly to protect consumers.

Pfizer has denied these claims and maintains that it only learned of the increased risk of meningiomas associated with the birth control shot in 2023. The manufacturer has frequently pointed out that they requested a label update in 2024, which the FDA rejected. Numerous other countries added a warning about the risk of developing brain meningiomas from use of the Depo-Provera product labels in 2024, and the delay in making such a change to U.S. labels has been widely criticized.

There’s been speculation and accusations that Pfizer’s 2024 request to the FDA was intentionally half-hearted so it could be used as a legal defense by the manufacturer, to say that they tried to warn consumers, but the FDA didn’t approve the request. But plaintiffs in the Depo-Provera brain meningioma MDL allege Pfizer knew or should have known of the risks long before 2024.

As dangerous product cases continue to be filed, the outcome of these claims is highly anticipated. Women who use the birth control shot and were diagnosed with a brain meningioma, and those who lost loved ones from this type of tumor, should consult with a Depo-Provera brain tumor lawyer to discuss their options. For more information or a free consultation, contact Childers, Schlueter & Smith at 1-800-641-0098, use our live chat, or contact us online.

Childers, Schlueter & Smith

Childers, Schlueter & Smith

Childers, Schlueter & Smith is a nationally practicing law firm committed to representing those in need. We offer years of experience, and to date, we have recovered more than $600 million in verdicts and settlements for our clients.

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